Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in number of dressing changes
研究概览
简要总结
The aim of the study is: to evaluate the efficacy of two post-operative dressings in the management of the surgical wounds in patients who received a knee prosthesis
详细描述
This was a randomised, controlled, clinical trial on patients who received a primary knee prosthesis in 2018-2019. Treatment group was given a multi-layer foam dressing with Safetac. The control group received standard treatment with povidone-iodine and a gauze dressing with plaster. 50 patients was needed for sufficient power. Primary outcome measures were; the characteristics of the surgical wound, patient reported comfort and adaptability according to the physiotherapist. Secondary outcome measures were: the clinical status and quality of life level according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Statistical analysis was performed by using IBM SPSS version 25, with a statistical significance of 5%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgical intervention of total primary knee prosthesis
- •Informed consent approved and signed by participants.
排除标准
- •Sensitivity or allergy to study dressings
研究组 & 干预措施
Multi-layer foam dressing
Patients in experimental group will receive the application of a multi-layer foam dressing with Safetac in surgical wound
干预措施: Multi-Foam dressing (Procedure)
Usual care
Patients in control group will receive standard treatment with povidone-iodine and a gauze dressing with plaster.
干预措施: Usual care (Procedure)
结局指标
主要结局
Change in number of dressing changes
时间窗: From fist day post-surgery to 7th postoperative day
Number of dressing applications to the patients required
次要结局
- Change in patient comfort(From fist day post-surgery to 7th postoperative day)
